World leading reliability
Cochlear understands that receiving a cochlear implant will be a life changing experience for you and your family. It is vital to consider reliability when making your choice of device, as you want your (or your child’s) implant to last as long as possible and ultimately you need to feel confident about your decision.
What gets reported?
The Nucleus Reliability Report makes available all data relating to cochlear implant device failures in accordance with the International Standard ISO 5841-2:20001 and the reporting principles described in the European and Global Consensus Statement on Cochlear Implant Failures and Explantations2,3. In compliance with the European and Global Consensus Statement, Cochlear reports all failures in the reliability calculation, including those caused by external impact and electrode failures that lead to a loss of clinical benefit. The data in each report covers the entire life of each device of all implant models and registered implants worldwide. Results for adults and children are shown separately with 95% confidence intervals as specifically required by the consensus statement.
Frequently asked questions
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Why does the reliability of Cochlear’s implants continue to improve?
Since launching the world’s first cochlear implant system in 1982, reliability has been a focus for Cochlear. This philosophy of continuous improvement made the CI24RE Series the most reliable implants available. No other device can claim as high a reliability record over seven years. This outstanding achievement contributes to the decision by seven out of ten cochlear implant recipients to choose Nucleus.
Why do I need to know about reliability?
Receiving a cochlear implant is a life changing experience:
- It is important that your implant (or your child’s) lasts as long as possible.
- You will want total confidence in the cochlear implant.
- you choose and that is right for you.
How is reliability measured?
Reliability is measured in two main ways:
- Cumulative Survival Rate (CSR) Percentage of implants functioning, at given time intervals, after implantation e.g.: If at five years, 10,000 devices have been implanted and 9,000 are fully functional, the CSR at five years would be 90%.
- Cumulative Failure Rate (CFR) Percentage of failed implants, at given time intervals, after implantation e.g.: If at one year, 1,000 devices have been implanted and five have failed, the CFR at one year would be 0.5%.
Both figures provide accurate measures. However, the cumulative failure rate has the advantage that differences in reliability are easier to detect.
Comparing reports from difference sources
In the hypothetical example below, two implants – type A and type B – are compared. At first glance, it appears that there is no substantial difference. After one year the values for implant survival (CSR) are 99.9% for type A and 99.2% for type B. Both figures and the graph imply that it is very unlikely to experience implant failure after one year. However, if looking at the corresponding figures for implant failures (CFR), it shows that the figures are 0.1% for type A and 0.8% for type B. Type B’s failure rate is 8 times higher than type A’s.
Figure 1: Hypothetical implant data CSR vs CFR
What is the definition of failure?
Cochlear’s definition of device failure and principles of best-practice reporting is in agreement with the consensus statement. Cochlear defines device failure as:
- any device that is explanted and out-of-specification resulting in the loss of clinical benefit; and
- any device that remains in-situ and is out-of-specification resulting in the loss of clinical benefit.
Nucleus reliability report
For full details on the reliability for all Cochlear Nucleus implants download the reliability report here.
Nucleus CI24RE Implant
Nucleus CI24RE Series cochlear implants are designed to work in synergy with the human cochlea.